{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "151910", "product_res_number": "Z-0907-2017", "event_date_initiated": "2016-11-21", "event_date_created": "2016-12-23", "recall_status": "Terminated", "event_date_terminated": "2017-09-26", "res_event_number": "75851", "product_code": "IZI", "k_numbers": [ "K974367" ], "product_description": "ADVANTX LCN+", "code_info": "Mfg. Lot or Serial #\tSystem ID 00000089619MO1\t205592MLC 00000089632MO4\t205592MLC 00000052196YY3\t601459LC 00000023729YY7\t910343NHC1 00000031441YY9\t603668CLC3 00000034211YY3\t603668CLC3 00000034271YY7\t973429CATH Not Available\t215576LC2 Not Available\t610250SC Not Available\t0910062022 Not Available\t0910062022 00000023777YY6\t1025 00000026231YY1\t3919-1 00000023841YY0\t93162 00000023841YY0\t93162 Not Available\tGOLD000540", "firm_fei_number": "2126677", "recalling_firm": "GE Healthcare, LLC", "address_1": "3000 N Grandview Blvd", "city": "Waukesha", "state": "WI", "postal_code": "53188-1615", "additional_info_contact": "Stephanie Cass\n800-437-1171", "reason_for_recall": "GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.", "root_cause_description": "Nonconforming Material/Component", "action": "Consignees were sent on 11/21/2016 a GE Healthcare \"Urgent Medical Device Correction\" letter GEHC Ref# FMI 10913 dated November 21, 2016. The letter was addressed to Director of Radiology, Risk Manager/Hospital Administrator, and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.", "product_quantity": "Total for all products 1,598 (USA 824, OUS 774)", "distribution_pattern": "US: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,NC, NE NH, NJ, NM, NY, NV, OH, OK, PA, RI, SC, SD, TN, TX,, VA, WA, WO, WY, WV. \n\nOUS: \n\nAlgeria\nArmenia\nAustralia\nAustria\nBrazil\nCanada\nChile\nChina\nDenmark\nEgypt\nFrance\nGermany\nGuatemala\nHonduras\nHong Kong\nHungary\nIceland\nIndia\nIreland\nItaly\nJapan\nKorea\nLibya\nMexico\nNetherlands\nNetherlands\nPeru\nPoland\nPortugal\nRussia\nSaudi Arabia\nSerbia\nSierra Leone\nSlovakia\nSpain\nTaiwan\nThailand\nTurkey\nUnited Arab Emirates\nUnited Kingdom\nVenezuela\nVietnam", "openfda": { "k_number": [ "K972136", "K130003", "K850455", "K915199", "K955519", "K875376", "K945400", "K875374", "K897115", "K875184", "K913685", "K182907", "K955179", "K984545", "K954581", "K991231", "K972655", "K810183", "K812238", "K222240", "K875375", "K880690", "K100371", "K892849", "K935026", "K170239", "K932410", "K910654", "K931184", "K151780", "K933058", "K062360", "K925961", "K180019", "K190772", "K993765", "K945449", "K945540", "K073290", "K842494", "K041027", "K905653", "K953563", "K230727", "K073088", "K082907", "K960575", "K974367", "K010721", "K934496", "K253181", "K903941", "K130842", "K973482", "K922222", "K042646", "K993947", "K052076", "K920434", "K945375", "K920705", "K993763", "K033184", "K041949", "K945459", "K903371", "K133993", "K090745", "K955395", "K970738", "K072591", "K073328", "K875380", "K261037", "K971489", "K982203", "K883860", "K010391", "K931170", "K926082", "K946378", "K903493", "K942120", "K883831", "K961451", "K875379", "K234090", "K945483", "K883072", "K923813", "K781991", "K083745", "K912416", "K113034", "K983877", "K896088", "K060749", "K141136", "K974679", "K936002", "K943355", "K904447", "K944952", "K903373", "K031333", "K042961", "K940484", "K214097", "K884008", "K921101", "K875372", "K913120", "K875373", "K905518", "K133719", "K941946", "K924708", "K924828", "K973368", "K080612", "K202391", "K941177", "K914376", "K100468", "K914313", "K923112", "K940172", "K941979", "K231986", "K945293", "K002840", "K970525", "K061871", "K991922", "K933664", "K072222", "K890352", "K971181", "K920862", "K162991", "K922804", "K063345", "K071037", "K111209", "K231075", "K942503", "K113594", "K903375", "K972229", "K052039", "K073130", "K930635", "K911732", "K812721", "K071717", "K924719", "K933460", "K915232", "K060867", "K192761", "K890348", "K852331", "K903372", "K874910", "K853044", "K933073", "K110256", "K243077", "K904540", "K071619", "K243645", "K971365", "K954309", "K834496", "K971176", "K882358", "K032443", "K181537", "K023441", "K023970", "K030139", "K926258", "K884912", "K072006", "K052500", "K811149", "K973270", "K100849", "K813588", "K943545", "K842495", "K973342", "K812913", "K910370", "K924137", "K922622", "K923654", "K902542", "K952704" ], "registration_number": [ "3015224777", "3014663814", "3007487007", "3006990600", "3009057691", "3017820152", "3042940623", "3015806723", "9610612", "3003755939", "3016607092", "3014321789", "3036666444", "3013700547", "3010684280", "3009963139", "3015180671", "3010157088", "3013868968", "3007138831", "8043903", "3015532525", "3012883081", "3020746799", "3009077524", "3011063460", "3006498370", "3031594238", "3003202425", "3007055152", "1220246", "3010193531", "1625425", "3010493171", "2936485", "3042243691", "3016851379", "3012470322", "3019269298", "3012627460", "1644312", "3031503890", "9710122", "3004519921", "3021393544", "2648727", "8030233", "3004111573", "3045816907", "3004026651", "3002579136", "3026934906", "3003974370", "1048735", "2523676", "3021226419", "2247992", "1000181430", "3011416394", "2521402", "9615010", "3008632256", "3015231789", "3015895145", "3015276088", "1018470", "3008284470", "3016555232", "3008309062", "3021336182", "3004122598", "3013767421", "3012127758", "3023003446", "3009715136", "3013665681", "3005369776", "3012329552", "3006972752", "3012624817", "3003637092", "3027339877", "3010326005", "3009719225", "1422634", "3000126629", "3027373189", "1043214", "3012075008", "9614683", "9613445", "3005810333", "3014004349", "3029968414", "3016832577", "3008496839", "3022626486", "3030926959", "3010331645", "3004977335", "3014635169", "9614698", "3015173212", "1061124", "3014262693", "3015232217", "1054713", "1037885", "3014644276", "3012761544", "3005877899", "3007289408", "3013283620", "3013077751", "1055236", "3011230048", "3010400367", "3020331900", "3016727307", "3020899789", "1036836", "3042175844", "3021059265", "3035950510", "3015910259", "3015974593", "3013764800", "3014343100", "3012345110", "8020997", "3033527282", "3038614464", "1319639", "3015612252", "3000976525", "3017619652", "2916714", "3012939903", "3020704423", "1054241", "9611343", "3026606306", "8010047", "3010885402", "1000204638", "3026391023", "3001675293", "3015153469", "3003768277" ], "fei_number": [ "3002807795", "1000138054", "3015224777", "3014663814", "3007487007", "3006990600", "3009057691", "3017820152", "3042940623", "3015806723", "3003755939", "3016607092", "3014321789", "3036666444", "1000514656", "3013700547", "3010684280", "3009963139", "3015180671", "3010157088", "3002806315", "3013868968", "3007138831", "3005846326", "3015532525", "3012883081", "3020746799", "3009077524", "3011063460", "3006498370", "3031594238", "3003202425", "3007055152", "1220246", "3010193531", "1625425", "3010493171", "2936485", "1000114111", "3042243691", "1000582291", "3016851379", "3012470322", "3019269298", "3012627460", "3031503890", "3021393544", "2648727", "3004111573", "3045816907", "1048735", "3002579136", "3026934906", "3003974370", "1000284313", "2523676", "3021226419", "1000181430", "3011416394", "2521402", "3008632256", "3015231789", "3015895145", "3006149253", "3015276088", "1018470", "3008284470", "3016555232", "3008309062", "3021336182", "3004122598", "3013767421", "3012127758", "3023003446", "3009715136", "3013665681", "3005369776", "3012329552", "3006972752", "3012624817", "3003637092", "3027339877", "3010326005", "3009719225", "3003794634", "3000126629", "3003481798", "3027373189", "1043214", "3002808139", "1000112968", "3012075008", "3002808088", "3005810333", "3014004349", "3029968414", "3016832577", "3008496839", "1000512168", "3022626486", "3030926959", "3010331645", "3004977335", "3014635169", "3015173212", "3014262693", "3015232217", "1037885", "3012761544", "3005877899", "3007289408", "3013283620", "1000117748", "3013077751", "1000208827", "3011230048", "1000112877", "3010400367", "3020331900", "3016727307", "3020899789", "1036836", "3042175844", "3021059265", "3035950510", "3003595527", "3015910259", "3015974593", "3013764800", "3014343100", "3002807880", "3012345110", "3033527282", "3038614464", "3015612252", "3000976525", "3002807092", "3017619652", "3002175190", "2916714", "3012939903", "3020704423", "3026606306", "3010885402", "1000204638", "3026391023", "3002808382", "3001675293", "3015153469" ], "device_name": "System, X-Ray, Angiographic", "medical_specialty_description": "Radiology", "regulation_number": "892.1600", "device_class": "2" } } ] }